510(k) · Cleared
ClearedVersaCross Steerable Sheath, VersaCross Transseptal Dilator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baylis Medical Company, Inc. · DYB Introducer, Catheter
Cleared on Apr 17, 2019 as substantially equivalent to K122926 (Baylis Medical Co., Inc., 2013) after a 30-day review. Its family tree reaches back 1 generation to 2013. 1 later device descends from it.
- Decided
- Apr 17, 2019
- Review
- 30 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K122926 (2013). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK122926 Sureflex Steerable Guiding Sheath KitBaylis Medical Co., Inc. · 2013
- This deviceK190688 VersaCross Steerable Sheath, VersaCross Transseptal DilatorBaylis Medical Company, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK232037 Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex…Innovative Health, LLC · 2024
Most influential descendants
Showing 1 of 1 · See all- K232037Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding SheathInnovative Health, LLC · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K122926 | Sureflex Steerable Guiding Sheath Kit | Baylis Medical Co., Inc. | 2013 | — |
| 0 (this device) | K190688 | VersaCross Steerable Sheath, VersaCross Transseptal Dilator | Baylis Medical Company, Inc. | 2019 | — |
| +1 | K232037 | Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable… | Innovative Health, LLC | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DYB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DYB device
- #1 K251051 AuST Steerable Sheathscore 18.0 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K122926 | Sureflex Steerable Guiding Sheath KitSummary page 4…cing various SureFlex Steerable Baylis Medical cardiovascular catheters to the heart, K122926 Guiding Sheath Company Inc. including the left side of the heart through the interatr… | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232037 | Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding Sheath | 2024 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · DYB
16in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DYB
63in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DYB
3in 2025
Class I (48 since 2007) Class II/III not classified
Adverse event reports per year · DYB
4,539in 2025
MAUDE reports naming product code DYB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 12 | 95 | 15 | 316 |
| 2008 | 17 | 37 | 9 | 423 |
| 2009 | 14 | 52 | 25 | 399 |
| 2010 | 18 | 123 | 18 | 445 |
| 2011 | 17 | 100 | 4 | 628 |
| 2012 | 22 | 128 | 3 | 898 |
| 2013 | 26 | 118 | 5 (1) | 743 |
| 2014 | 30 | 122 | 2 | 780 |
| 2015 | 17 | 129 | 2 (1) | 913 |
| 2016 | 19 | 95 | 45 (3) | 1,234 |
| 2017 | 24 | 70 | 22 (1) | 1,672 |
| 2018 | 19 | 156 | 1 | 1,903 |
| 2019 | 18 | 47 | 2 | 2,450 |
| 2020 | 9 | 49 | 21 (21) | 2,465 |
| 2021 | 12 | 78 | 6 | 2,835 |
| 2022 | 13 | 143 | 2 | 4,084 |
| 2023 | 15 | 55 | 10 | 3,775 |
| 2024 | 18 | 56 | 2 | 3,931 |
| 2025 | 16 | 63 | 3 | 4,539 |
| 2026 | 17 | 59 | 23 (21) | — |
What is it indicated for?
The VersaCross Steerable Sheath and VersaCross Transseptal Dilator is indicated for introducing various cardiovascular catheters to the heart, including the left side of the heart through the interatrial septum.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K190688 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190688: VersaCross Steerable Sheath, VersaCross Transseptal Dilator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190688
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026